BR102017010312A2 - Apparatus and method for measuring the concentration of disinfectant in a medical device re-inspection system - Google Patents

Abstract

The present invention relates to a medical instrument processor including a housing, a liquid dispensing system and a disinfectant concentration measurement subsystem. The housing is configured to contain a medical instrument. The liquid delivery system is configured to apply a disinfection solution to a medical instrument within the enclosure. The liquid dispensing system has a liquid outlet. The disinfectant concentration measurement subsystem includes a first mixing chamber in fluid communication with the liquid outlet, a pump that is configured to simultaneously pump disinfecting solution and reagent solution into the first mixing chamber, and a set of Concentration analysis, which is operable to determine a concentration of disinfectant in a sample solution that is emitted from the first mixing chamber. the reservoir is in fluid communication with the first mixing chamber.

Description

Report of the Invention Patent for "APPARATUS AND METHOD FOR MEASURING DISINFECTANT CONCENTRATION IN A MEDICAL DEPARTMENT SYSTEM".

BACKGROUND

The discussion below relates to reprocessing ie decontamination of endoscopes and other instruments that are used in medical procedures. In particular, the discussion below relates to an apparatus and method that can be used to reprocess a medical device such as an endoscope after the medical device has been used in a medical procedure so that the medical device can be safely used. in a subsequent medical procedure. While the following discussion refers primarily to an endoscope, it should be understood that the discussion may also apply equally to other particular medical devices.

An endoscope may have one or more working channels or lumens extending over at least a portion of the length of the endoscope. These channels can be configured to provide a route for the passage of other medical devices, etc., in a patient's anatomical region. These channels may be difficult to clean and / or disinfect and clean using certain primitive cleaning and / or disinfection techniques. In this way, the endoscope can be placed in a reprocessing system that is particularly configured to clean endoscopes, including channels within endoscopes. Such an endoscope reprocessing system can wash and disinfect the endoscope. Such an endoscope reprocessing system may include a basin that is configured to receive the endoscope, with a pump that flows cleaning fluids over the outside of the endoscope into the basin. The system may also include ports that engage the endoscope's working channels and associated pumps that flow cleaning fluids through the endoscope's working channels. The process performed by such a dedicated endoscope reprocessing system may include a detergent wash cycle followed by a rinse cycle followed by a sterilization or disinfection cycle followed by another rinse cycle. The sterilization or disinfection cycle may employ disinfecting solution and water rinses. The process may optionally include an alcohol discharge to aid in water displacement. The rinse cycle may be followed by an air discharge for drying and storage.

Examples of systems and methods that can be used to reprocess a used endoscope are described in US Patent No. 6,986,736, entitled "Automated Endoscope Reprocessor Connection with Integrity Testing", issued January 17, 2006, which is disclosed. incorporated herein by reference; US Patent No. 7,479,257, entitled "Automated Endoscope Reprocessor Solution Testing", issued January 20, 2009, the disclosure of which is incorporated herein by reference; US Patent No. 7,686,761, entitled "Method of Detecting Proper Connection of an Endoscope to an Endoscope Reprocessor", issued March 30, 2010, the disclosure of which is incorporated herein by reference; and Patent No. 8,246,909, entitled "Automated Endoscope Reprocessor Germicide Concentration Monitoring System and Method", issued August 21, 2012, the disclosure of which is incorporated herein by reference. An example of a commercially available endoscope reprocessing system is the EVOTECH® ECR Endoscope Cleaner and Reprocessor, available from Advanced Sterilization Products of Irvine, California.

For the sterilization or disinfection cycle of an endoscope reprocessing system to be effective, it may be important to ensure that the disinfection solution is sufficiently concentrated. In systems where the disinfection solution is recirculated and reused within an endoscope reprocessing system to clean multiple endoscopes, the disinfectant in the disinfection solution may become increasingly diluted, particularly by any residual rinse water remaining. into the system after rinse cycles occur. Accordingly, it may be prudent to evaluate the disinfectant concentration in the disinfectant solution between cycles and replace the disinfectant solution when it becomes too diluted to be effective.

Conventional systems and some techniques may provide manual methods for assessing disinfectant concentration in the disinfection solution of an endoscope reprocessing system. For example, the system user may expose a test strip to a sample of the disinfection solution and observe the strip for a color change that is indicative of a disinfectant concentration that is below an effective concentration. Due to the fact that such a test strip method is subjective, it may be inaccurate. In addition, the test strip method may increase the risk of operator exposure to disinfectant. Alternatively, the system operator may send a sample of the disinfection solution to a third party laboratory to measure disinfectant concentration by high performance liquid chromatography. In addition to being time consuming and expensive, the method can also increase the risk of operator exposure to disinfectant.

The concentration of certain disinfectants, such as aldehydes, can be measured by passing light through a sample containing the disinfectant and measuring its absorbance by means of an automated process that is integrated with a reprocessing system. endoscope. However, this method can be distinguished by several limitations. For example, the concentration of aldehyde in the sample may need to be relatively low, otherwise the aldehyde may absorb all light passing through the sample, which may make a significant absorbance reading impossible. In addition, the accuracy of this method may be vulnerable to potential interference materials in the solution, such as bioburden and / or aging / oxidation of by-products in the sample. Therefore, it may be desirable to provide a system and method that is not sensitive to potential interference materials in the disinfectant solution; and that is usable over a wide range of disinfectant concentration.

Although a variety of systems and methods have been devised and used to reprocess medical devices, it is believed that no one prior to the inventor or inventors created or used the technology as described herein.

BRIEF DESCRIPTION OF DRAWINGS

It is believed that the present invention will be better understood from the following description of specific examples taken in conjunction with the accompanying drawings, in which similar reference numerals identify the same elements and in which: Figure 1 represents a front elevational view of an exemplary reprocessing system;

[0010] Figure 2 is a schematic diagram of the reprocessing system of Figure 1, showing only one decontamination basin for the sake of clarity;

[0011] Figure 3 is a cross-sectional side view of proximal and distal portions of an endoscope that can be decontaminated using the reprocessing system of Figure 1;

Figure 4 is a diagrammatic illustration of a disinfectant concentration measurement subsystem that may be incorporated into the reprocessing system of Figure 1;

Figure 5 is a diagrammatic illustration of an optical portion of the disinfectant concentration measurement subsystem of Figure 4; and Figure 6 is a flowchart of a method that can be performed using the disinfectant concentration measurement sub of Figure 4 to measure a concentration of a disinfectant in a disinfectant solution.

DETAILED DESCRIPTION

The following description of certain examples of technology should not be used to limit its scope. Other examples, features, aspects, modalities, and advantages of the technology will become apparent to those skilled in the art with the following description, which is by way of illustration, one of the best contemplated modes for realizing the technology. As will be understood, the technology described herein is capable of other different and obvious aspects, all without disregarding the invention. Accordingly, the drawings and descriptions are to be considered as illustrative and not restrictive in nature.

It is further understood that any one or more of the teachings, expressions, modalities, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. which are described in the present invention. The teachings, expressions, modalities, examples etc. described below should not be viewed in isolation from each other. Various suitable ways in which the teachings of the present invention may be combined will be readily apparent to those skilled in the art in view of the teachings of the present invention. Such modifications and variations are intended to be included within the scope of the appended claims. I. Exemplary Medical Device Reprocessing Apparatus Figures 1 to 2 show an exemplary reprocessing system 2 that can be used to decontaminate endoscopes and other medical devices including channels or lumens formed therethrough. System 2 of this example generally includes a first station 10 and a second station 12. Stations 10, 12 are at least substantially similar in all respects for providing decontamination of two different medical devices simultaneously or in series. The first and second decontamination basins 14a, 14b receive the contaminated devices. Each basin 14a, 14b is selectively sealed by a respective lid 16a, 16b. In the present example, lids 16a, 16b cooperate with respective basins 14a, 14b to provide a microbial blocking relationship to prevent environmental microbes from entering basins 14a, 14b during decontamination operations. By way of example only, caps 16a, 16b may include a microbial or HEPA removed air filter formed therefor for ventilation.

[0018] A control system 20 includes one or more microcontrollers, such as a PLC programmable logic controller, for controlling decontamination and user interface operations. Although a control system 20 is shown in the present invention as controlling both decontamination stations 10, 12, those skilled in the art will recognize that each station 10, 12 may include a dedicated control system. A visual display 22 shows an operator decontamination parameters and machine conditions, and at least one printer 2 prints a physical copy of the decontamination parameter output so that a record is deposited or attached to the decontaminated device or its storage container. . It should be understood that the printer 24 is merely optional. In some versions, visual display 22 is combined with a touch screen input device. Additionally or alternatively, a keyboard and / or other user input feature is provided for input of decontamination process parameters and for machine control. Other visual gauges 26, such as pressure gauges and the like, provide digital or analog output of data for decontamination or leak testing of the medical device.

Figure 2 diagrammatically illustrates only one decontamination station 10 of a reprocessing system 2, but those skilled in the art will recognize that the decontamination station 12 can be configured and operable in the same manner as the decontamination station 10. It should also be It is understood that the reprocessing system 2 may be provided with only a single decontamination station 10, 12, or more than two decontamination stations 10, 12.

The decontamination basin 14a therein receives an endoscope 200 see Figure 3 or another medical decontamination device. Any internal channels of endoscope 200 are connected to discharge ducts, such as 30 discharge lines. Each discharge line 30 is connected to an outlet of a corresponding pump 32, so that each discharge line 30 has a dedicated pump 32 in this example. The pumps 32 of the present example comprise peristaltic pumps that pump fluid, such as liquid and air, through discharge lines 30 and any internal channels of endoscope 200. Of course, any other suitable type of pump (or pumps) may be used. In the present example, pumps 32 may draw liquid from basin 14a through a filtered drain 34 and a valve S1; or extracting decontaminated air from an air supply system 36 through a valve S2. The air supply system 36 of the present example includes a pump 38 and a microbe removal air filter 40, which filters microbes from an inlet air stream.

A switch or pressure sensor 42 is in fluid communication with each discharge line 30 to detect overpressure therein. Any excessive pressure or lack of flow detected may be indicative of a partial or complete blockage (for example, by dry body fluids or body fluids) in an endoscope channel 200 to which the discharge line 30 in question is connected. Isolation of each discharge line 30 from other discharge lines 30 allows the specific blocked channel to be easily identified and isolated, depending on which sensor 42 detects excessive pressure or lack of flow.

Bowl 14a is in fluid communication with a water source 50, such as a utility or tap water connection including hot and cold inlets, and a mixing valve 52 that flows into a separating tank 56. A microbe removal filter 54, such as an absolute pore size filter of 0.2 µm or less, decontaminates the inlet water that is transported into the separation tank 56 through the air gap to prevent backflow. A sensor 59 monitors liquid levels within basin 14a. An optional 53 water heater may be provided if a suitable source of hot water is not available. The condition of the filter 54 can be monitored directly by monitoring the water flow through it or indirectly by monitoring the basin fill time using a float switch or the like. When flow falls below a selected threshold, this indicates a partially clogged filter element that requires replacement.

A basin drain 62 drains liquid from basin 14a through an enlarged helical tube 64 into which elongated portions of endoscope 200 may be introduced. The drain 62 is in fluid communication with a recirculation pump 70 and a pump. 72. The recirculation pump 70 recirculates the basin drain liquid 62 into a sprinkler nozzle assembly 60, which sprays the liquid into the basin 14a and over endoscope 200. A coarse screen 71 and a thin screen 73 filters the particles in the recirculating fluid. Drain pump 72 pumps the basin drain liquid 62 to a utility drain 74. A level sensor 76 monitors the flow of liquid from pump 72 to utility drain 74. Pumps 70, 72 can be simultaneously so that liquid is sprayed into the basin 14a while the basin 14a is draining to favor the flow of debris out of the basin 14a and away from endoscope 200. Of course a single pump and a set of valve could replace dual pumps 70, 72.

An in-line heater 80 with temperature sensors 82 upstream of recirculation pump 70 heats the liquid to optimum temperatures for cleaning and / or disinfection. A pressure switch or pressure sensor 84 measures the downstream pressure of the circulation pump 70. In some variations, a flow sensor is used instead of the pressure sensor 84 to measure the downstream fluid flow of the circulation pump 70. Detergent solution 86 is measured in the downstream flow of the circulation pump 70 by a metering pump 88. A float switch 90 indicates the available detergent level 86. Disinfectant 92 is measured in the upstream flow of circulation pump 70 by means of a metering pump 94. To more accurately measure disinfectant 92, a dispensing pump 94 fills a metering pre-chamber 96 under the control of a wrench. fluid level 98 and control system 20. By way of example only, disinfectant solution 92 may comprise CIDEX © Activated Glutaraldehyde Solution, available from Advanced Sterilization Products of Irvine, California. By way of example only, disinfecting solution 92 may comprise orthophthalaldehyde (OPA). By way of example only, disinfecting solution 92 may comprise peracetic acid (PAA).

Some endoscopes 200 include a flexible outer sheath or sheath surrounding the individual and similar tubular elements forming the inner channels and other parts of the endoscope 200. This sheath defines an enclosed inner space which is isolated from the tissues and patient fluids during medical procedures. It may be important that the sheath be kept intact without cuts or other holes that could allow contamination of the inner space beneath it. Therefore, the reprocessing apparatus 2 of the present example includes means for testing the integrity of this sheath. In particular, an air pump (e.g., pump 38 or other pump 110) pressurizes the internal space defined by endoscope sheath 200 through a conduit 112 and a valve S5. In the present example, a HEPA filter or other microbe remover filter 113 removes microbes from the air for pressurization. A pressure regulator 114 prevents the accidental occurrence of excessive sheath pressurization. When full pressurization is reached, valve S5 is closed, and a pressure sensor 116 looks for a drop in pressure within conduit 112, which would indicate air escaping through endoscope sheath 200. A valve S6 selectively ventilates the conduit 112 and endoscope sheath 200 via an optional filter 118 when the test procedure is complete. An air cap 120 softens the pressure pulse from the air pump 110.

In the present example, each station 10, 12 also contains a drip bowl 130 and a splash sensor 132 to alert the operator of possible leaks.

An alcohol supply 134, controlled by an S3 valve, can supply alcohol to channel 32 pumps after the rinse steps to help remove water from endoscope channels 210, 212, 214, 217, 218. 200.

Flow rates in supply lines 30 may be monitored by channel pumps 32 and pressure sensors 42. If one of the pressure sensors 42 detects an excessively high pressure, the associated pump 32 is deactivated. Pump flow rate 32 and its activated runtime provide a reasonable indication of the flow rate on an associated line 30. These flow rates are monitored during the process for blockages on any of the endoscope channels 200. Alternatively, the drop in Pressure from the time pump 32 stops cycling can also be used to estimate flow, with higher velocity drops being associated with higher flow rates.

More accurate measurement of flow in an individual channel may be desirable to detect more subtle blockages. To this end, a metering tube 136 having a plurality of level indication sensors 138 fluidly connects to channel pump inlets 32. In some versions, the reference connection is provided at a low point in the metering tube. 136 and a plurality of sensors 138 are arranged vertically above the reference connection. By passing a current from the reference point through the fluid to the sensors 138, one can determine which sensors 138 are immersed and thus determine the level inside the measuring tube 136. In addition, or alternatively, any Other suitable components and techniques may be used to detect fluid levels. By closing valve S1 and opening a breather valve S7, channel pumps 32 draw exclusively from metering tube 136. The amount of fluid being extracted can be very precisely determined from sensors 138. By passing For each of the isolated channel pumps 32, the flow through them can be precisely determined based on the time and volume of fluid emptied from the metering tube 136.

In addition to the input and output devices described above, all electrical and electromechanical devices shown are operatively connected and controlled by the control system 20. Specifically, and without limitation, switches and sensors 42, 59, 76, 84, 90, 98, 114, 116, 132, 136 provide input I to the microcontroller 28, which controls the cleaning and / or infection cycles and other machine operations accordingly. For example, microcontroller 28 includes outputs O which are operatively connected to pumps 32, 38, 70, 72, 88, 94, 100, 110, valves S1, S2, S3, S5, S6, S7 and the heater. 80 to control such devices for effective cleaning and / or decontamination cycles and other operations.

As shown in Figure 3, endoscope 200 has a head portion 202. The head portion 202 includes openings 204, 206 formed therein. During normal use of endoscope 200, a not shown air / water valve and a not shown suction valve are disposed in the openings 204, 206. A flexible insertion tube 208 is attached to the head portion 202. 210 and a combined suction / biopsy channel 212 are accommodated in the insertion tube 208. An air channel 213 and the water channel 214 are also arranged in the head portion 202 and integrate into the air / water channel 210 in a location of a junction point 216.

It will be understood that the term "joining point" as used herein refers to an intersection junction, rather than being limited to a geometric point, and the terms may be used interchangeably. In addition, a separate suction channel 217 and a separate biopsy channel 218 are accommodated in the head portion 202 and integrate into the suction / biopsy channel 212 at the site of a joint point 220.

In the head part 202, air channel 213 and water channel 214 open in opening 204 for air / water valve (not shown). Suction channel 217 opens in opening 206 for the suction valve (not shown). In addition, a flexible feed hose 222 is connected to the head portion 202 and accommodates channels 213 ', 214', 217 'which are connected to air channel 213, water channel 214 and suction channel 217 by means of respective openings 204, 206. In practice, the supply hose 222 may also be referred to as the light-conductive housing. Mutually connected air channels 213, 213 'will be collectively called below air channel 213. Mutually connected water channels 214, 214' can be collectively called water channel 214. Mutually connected suction channels 217, 217 ' collectively referred to as suction channel 217. A fitting 226 for air channel 213, fittings 228, 228a for water channel 214, and a fitting 230 for suction channel 217 are disposed at end section 224 (also light conductor connector) of flexible hose 222. When fitting 226 is in use, fitting 228a is closed. A connection 232 to the biopsy channel 218 is disposed in the head portion 202.

A channel separator 240 is shown inserted into the openings 204, 206. The channel separator 240 comprises a body 242 and plug members 244, 246, which occlude respective openings 204, 206. A coaxial insert 248 over the member of plug 244 extends into opening 204 and terminates in an annular flange 250, which occludes a portion of opening 204 to separate channel 213 from channel 214. By connecting lines 30 to openings 226, 228, 228a, 230, 232, cleaning and disinfecting liquid may be fluid through endoscope channels 213, 214, 217, 218 and out of an endoscope distal end 252 200 through channels 210, 212. Channel separator 240 ensures that such liquid flow all the way through endoscope 200 without leakage from openings 204, 206; and isolated channels 213, 214 each other, so that each channel 213, 214 has its own independent flow path. The skilled artisan will understand that various endoscopes with different channel and aperture arrangements may require modifications to channel separator 240 to accommodate such differences while occluding ports in head 202 and keeping channels separate from each other, so that each channel can be purged independently of the others. Otherwise a lock on one channel can simply redirect the flow to a connected and unlocked channel.

A leakage port 254 at end section 224 leads into an internal portion 256 of endoscope 200, and is used to verify physical integrity thereof, specifically to ensure that no leakage has formed between any of the channels and inner portion 256, or from outer portion to inner portion 256. II. Example medical device reprocessing method [0035] In an example of using system 2 reprocessing, an operator may start by depressing a foot pedal (not shown) to open the bowl lid 16a. Each cover 16a, 16b may have their own pedal. In some versions, once the pressure is removed from the pedal, the cap movement stops 16a, 16b. With lid 16a open, the operator inserts endoscope insertion tube 208 into a coil circulation tube 64. End section 224 and head section 202 of endoscope 200 are located within bowl 14a with the spiral-wound feed 222 into bowl 14a as wide as possible. Thereafter, discharge lines 30 are attached to respective endoscope openings 226, 228, 228a, 230, 232. An air line 112 is also connected to connector 254. In some versions, discharge lines 30 are color coded, and The tab located on station 10 provides a reference to color-coded connections.

Depending on the user selectable configuration, the control system 20 may require the operator to enter a user code, patient ID, endoscope code and / or specialist code. This information may be entered manually (eg via the touchscreen 22), automatically (eg using a barcode reader), or in any other suitable manner. With the information (if required), the operator can then close the lid 16a. In some versions, closing cap 16a requires the operator to simultaneously press a hardware button and a button on the touchscreen 22 (not shown), so as to provide a fail-safe mechanism to prevent the operator's hands. pinched or pinched by the bowl lid 16a. If one of the hardware or software buttons is released while lid 16a is in the process of closing, movement of lid 16a is stopped.

Once the lid 16a is closed, the operator presses a button on the touchscreen 22 to begin the washing / disinfection process. At the beginning of the washer / disinfection process, air pump 38 is activated and the pressure inside the endoscope body is monitored 200. When the pressure reaches a predetermined level (eg 250 hPa (250 mbar)), the pump 38 is deactivated, and the pressure is allowed to stabilize over a stabilization period (e.g. 6 seconds). If the pressure has not reached a certain pressure (eg 250 hPa (250 mbar)) within a certain period of time (eg 45 seconds), the program is interrupted and the operator is notified of a leak. If the pressure drops below a limit (eg to less than 100 hPa (100 mbar)) during the stabilization period, the program is interrupted and the user notified of the condition. Once the pressure has stabilized, the pressure drop is monitored over a certain period of time (eg 60 seconds). If the pressure drop is faster than a predetermined rate (for example, more than 10 hPa (10 mbar) within 60 seconds), the program is stopped and the user is notified of the condition. If the pressure drop is slower than a predetermined rate (e.g. 10 hPa (10 mbar) in 60 seconds), reprocessing system 2 continues to the next step. Slightly positive pressure is maintained within the endoscope body 200 throughout the rest of the process to prevent fluid from leaking into the endoscope.

A second leak test verifies the suitability of connection to the various Ports 226, 228, 228a, 230, 232, and the proper placement of the splitter channel 240. An amount of water is admitted to the basin 14a so as to submerge the distal end of endoscope 200 in the helical tube 64. S1 is closed valve and open valve S7; 32 and pumps are performed in reverse to remove a vacuum and to finally draw liquid into endoscope channels 210, 212. Pressure sensors 42 are monitored to ensure that pressure in either channel 210, 212 does not fall or rise more than a predetermined amount over a certain period of time.

If this occurs, it probably indicates that one of the connections was not made correctly and that there is an air leak into channel 210, 212. However, in the presence of an unacceptable pressure drop, the control system 20 will cancel the cycle. and will indicate a likely faulty connection, preferably with an indication of which channel 210, 212 failed.

In the event that leak tests are passed, reprocessing system 2 continues with a pre-rinse cycle. The purpose of this step is to discharge water through channels 210, 212, 213, 214, 217, 218 to remove residual material before washing and disinfecting endoscope 200. Bowl 14a is filled with filtered water, and water level is detected by pressure sensor 59 below the basin 14a. Water is pumped by means of pumps 32 through channels 210, 212, 213, 214, 217, 218, drainage 74 directly. This water is not recirculated around the outer surfaces of endoscope 200 during this stage. As water is being pumped through channels 210, 212, 213, 214, 217, 218, the drain pump 72 is activated to ensure that the basin 14a is also emptied. Drain pump 72 will shut down when drain switch 76 detects that the drainage process is complete. During the drainage process, sterile air is blown through the air pump 38 through all endoscope channels 210, 212, 213, 214, 217, 218 simultaneously to minimize possible permanence.

Once the prewash cycle is complete, 2 reprocessing system continues with a wash cycle. To begin the wash cycle, basin 14a is filled with hot water (e.g., approximately 35 * C). The water temperature is controlled by controlling the heated and unheated water mixture. The water level is detected by the pressure sensor 59. Processing 2 then the system adds enzymatic detergent to the circulating water in the reprocessing system 2 by means of the peristaltic metering pump 88. The volume is controlled by controlling the application time, pump speed and inner diameter of the peristaltic pump 88 tubing. A detergent solution 86 is actively pumped through all internal channels of the endoscope 210, 212, 213, 214, 217, 218 and over the surface. endoscope 200 for a predetermined period of time (for example, from one to five minutes, or more particularly about three minutes) via channel pumps 32 and external circulation pump 70. In-line heater maintains temperature 80 at a predetermined temperature (e.g. approximately about 35 ° C).

After the detergent solution has been circulating 86 for a certain period of time (e.g., two minutes), the flow rate through channels 210, 212, 213, 214, 217, 218 is measured. If the flow through any channel 210, 212, 213, 214, 217, 218 is less than a predetermined rate for that channel 210, 212, 213, 214, 217, 218, channel 210, 212, 213, 214, 217 , 218 is identified as blocked, the program is interrupted, and the operator is notified of the condition. Peristaltic pumps 32 are operated at their predetermined flow and cycle interrupted in the presence of unacceptably high pressure readings at the associated pressure sensor 42. If a channel 210, 212, 213, 214, 217, 218 is blocked, the predetermined flow will activate. pressure sensor 42, indicating the inability to adequately pass this flow. Since pumps 32 are peristaltic in the present example, their operating flow combined with the percentage of time during which they have their cycle interrupted due to pressure will provide the actual flow. Flow can also be estimated based on the pressure drop from the time pump 32 has stopped.

At the end of the wash cycle, a drain pump 72 is activated to remove detergent solution from basin 86 and 14a of channels 210, 212, 213, 214, 217, 218. Drain pump 72 shuts off when drain level sensor 76 indicates that drainage is complete. During the drainage process, sterile air is blown through all endoscope channels 210, 212, 213, 214, 217, 218 simultaneously to minimize possible permanence.

After the wash cycle is completed, reprocessing system 2 begins a rinse cycle. To initiate the rinse cycle, basin 14a is again filled with hot water (for example, at approximately 35 Ό). The water temperature is controlled by controlling the heated and unheated water mixture. Water level is detected by pressure sensor 59. Rinse water is circulated within channels 210, 212, 213, 214, 217, 218 of endoscope 200 through channel pumps 32; and on the outside of endoscope 200 by means of the circulation pump 70 and spray arm 60 for a certain period of time (e.g., one minute). As rinse water is pumped through channels 210, 212, 213, 214, 217, 218, the flow through channels 210, 212, 213, 214, 217, 218 is measured and if it falls below the predetermined rate for any channel 210, 212, 213, 214, 217, 218, that channel 210, 212, 213, 214, 217, 218 is identified as blocked, the program is interrupted, and the operator is notified of the condition.

At the end of the rinse cycle, drain pump 72 is activated to remove rinse water from basin 14a and channels 210, 212, 213, 214, 217, 218. Drain pump 72 shuts off when drain level sensor 76 indicates that drainage is complete. During the drainage process, sterile air is blown through all channels 210, 212, 213, 214, 217, 218 of endoscope 200 simultaneously to minimize possible stay. In some versions, the above described wash and drain cycles are repeated at least once to ensure maximum rinse of detergent solution 86 from the surfaces of endoscope 200 and bowl 14a.

After system 2 reprocessing has completed the desired number of wash and dry cycles, reprocessing system 2 proceeds to a disinfection cycle. To initiate the disinfection cycle, basin 14a is filled with very hot water (for example, at approximately 53 ° C). The water temperature is controlled by controlling the heated and unheated water mixture. The water level is detected by the pressure sensor 59. During the filling process, the channel pumps 32 are turned off to ensure that the disinfecting solution 92 in the basin 14a is in use before circulating through the channels. 210, 212, 213, 214, 217, 218 of endoscope 200.

Thereafter, a measured volume of disinfectant solution 92 is extracted from the disinfectant measuring pre-chamber 96 and released into the water in basin 14a by means of metering pump 100. The volume of disinfectant solution 92 is controlled. by positioning the fill level switch 98 relative to the bottom of the measuring chamber 96. The measuring chamber 96 is filled until the fill level switch 98 detects liquid. Disinfection solution 92 is extracted from measuring chamber 96 to the level of disinfection solution 92 in measuring chamber 96 is just below the measuring chamber tip 96. After the required volume be dispensed, the measuring chamber 96 is replenished from the disinfecting solution bottle 92. Disinfecting solution 92 is not added until basin 14a is filled so that if there is a problem with the disinfection the disinfectant concentrate is not left in the scope 200 without water to rinse it. While disinfecting solution 92 is being added, channel pumps 32 are turned off to ensure that disinfecting solution 92 in basin 14a is at the intended use concentration before circulating through channels 210, 212, 213, 214, 217. 218 of endoscope 200.

The disinfectant solution in use 92 is actively pumped through internal channels 210, 212, 213, 214, 217, 218 by pumps 32 and onto the outer surface of endoscope 200 via circulation pump 70. This can be accomplished. at any appropriate time (eg at least 5 minutes). The temperature of the disinfecting solution 92 may be controlled by the in-line heater to be at 80 ° C of a consistent temperature (e.g., about 52.5 ° C). During the disinfection process, the flow through each endoscope channel 210, 212, 213, 214, 217, 218 is verified by measuring the passage time of a measured amount of solution through channel 210, 212, 213, 214, 217, 218. Valve S1 is closed, and valve S7 open, and in turn each channel pump 32 distributes a predetermined volume to its associated channel 210, 212, 213, 214, 217, 218 of the metering tube. 136. This volume and the time required to release the volume present a very accurate flow through channel 210, 212, 213, 214, 217, 218. Flow anomalies from what is expected for a channel 210, 212, 213 , 214, 217, 218 with certain diameter and length are pointed by the control system 20 and the process is interrupted. In use as disinfecting solution 92 is pumped through channels 210, 212, 213, 214, 217, 218, the flow rate through channels 210, 212, 213, 214, 217, 218 is also measured as described above.

At the end of the disinfection cycle, 72 of the drain pump is activated to remove disinfection solution 92 from basin 14a and channels 210, 212, 213, 214, 217, 218. During the drainage process, Sterile air is blown through all channels 210, 212, 213, 214, 217, 218 of endoscope 200 simultaneously to minimize possible stay. As will be described in more detail below, in some versions, the disinfection solution 92 used is tested to determine if the concentration level is within an acceptable range or if the disinfection solution 92 used has been diluted to a point where Used 92 is disinfection below a certain concentration threshold. If the used disinfecting solution 92 has an acceptable concentration level, the disinfecting solution 92 may be used in subsequent disinfection cycles. If the disinfection solution 92 used is at a concentration below the threshold, the disinfection solution 92 may be discarded (for example by means of drain 74).

After disinfection solution 92 has been drained from basin 14a, reprocessing system 2 begins a final rinse cycle. At the start of the cycle, 14a, it is filled with sterile warm water (for example, at approximately 45 ° C) that has been passed through a filter (for example, a 0.2 pm filter). Rinse water is circulated within channels 210, 212, 213, 214, 217, 218 by good baseboats32; and on the outside of the endoscope by means of the circulation pump 200 and 70 of the spray arm 60 for a suitable time (e.g. 1 minute). As rinse water is pumped through channels 210, 212, 213, 214, 217, 218, the flow through channels 210, 212, 213, 214, 217, 218 is measured as described above. Drain pump 72 is activated to remove rinse water and channel basin 14a of channels 210, 212, 213, 214, 217, 218. During the drainage process, sterile air is blown through all channels 210, 212, 213, 214, 217, 218 of endoscope 200 simultaneously to minimize possible stay. In some embodiments, the wash and drain cycles described above are repeated at least twice more to ensure maximum disinfection solution residue 92 from the surfaces of endoscope 200 and bowl 14a.

After the final rinse cycle is completed, reprocessing system 2 begins a final leak test. In particular, the reprocessing system 2 pressurizes the endoscope body 200 and measures the leakage rate as described above. If the final leak test is successful, reprocessing system 2 indicates successful completion of the cycles via the touch screen 22. From the time the program completes and until the lid 16a is opened, the pressure within the endoscope body 200 is normalized to atmospheric pressure by opening breather valve S5 at a predetermined rate (e.g., valve S5 open for 10 seconds every minute).

Depending on the configuration selected by the customer, reprocessing system 2 may prevent cover 16a from being opened until a valid user identification code is entered. Information about the completed program, including user ID, endoscope ID, specialist ID, and patient ID is stored along with sensor data obtained throughout the program. If a printer is connected to reprocessing system 2, and if requested by the operator, a disinfection program log will be printed. Once a valid user identification code is entered, the cover 16a can be opened (using the pedal as described above). Endoscope 200 is then disconnected from discharge lines 30 and removed from bowl 14a. The lid 16a can then be closed using both hardware and software buttons as described above. III. Example disinfectant concentration measurement subsystem [0052] As noted above, some versions of reprocessing system 2 may only provide a single use of a given volume of disinfecting solution 92, so that disinfecting solution volume 92 discarded after a single use of disinfection solution volume 92 upon completion of the disinfection cycle. As also noted above, some other versions of reprocessing system 2 may check the concentration level of a used disinfecting solution volume 92 and either reuse the used disinfecting solution 92 (ie if the concentration level is still acceptable) how to discard the disinfection solution 92 used (ie if the concentration level is no longer acceptable). Merely illustrative examples of reprocessing system 2 providing monitoring and reuse of disinfection solution 92 are set forth in US Patent No. 8,246,909 entitled "Automated Endoscope Germicide Concentration Monitoring System and Method", issued August 21, 2001. 2012, the disclosure of which is incorporated herein by reference; and / or US Patent Application No. [Attorney Summary No. ASP5110USNP.0635277] entitled "Apparatus and Method for Reprocessing a Medical Device" filed on the same date as the present application, the disclosure of which is incorporated herein by reference. .

Figures 4 to 5 show diagrammatic illustrations of an exemplary disinfectant concentration measurement subsystem 400, hereinbelow, "subsystem 400". Subsystem 400 measures the disinfectant concentration of disinfection solution 92 that is used and often recirculated and reused in reprocessing system 2. Although subsystem 400 in this example can be used to measure the concentration of disinfectant solution 92 in system 2 comprising both a station 10 and, optionally, two stations 10, 12, it is contemplated herein that a subsystem 400 may be readily adapted by a person skilled in the art to sample the decay solution 92 of a reprocessing system which comprises three or more stations. Subsystem 400 can be combined with reprocessing system 2 in various ways. For example, subsystem 400 may be fully integrated into a reprocessing system 2. In another example, subsystem 400 may be provided as a separate stand-alone unit that is placed in fluid communication with a reprocessing system 2 (e.g. via coupling subsystem 400 with reprocessing system 2 via a fluid conduit, etc.). Also, it should be understood that subsystem 400 may be incorporated into reprocessing system 2 according to the teachings of U.S. Patent No. 8,246,909 and / or teachings of US patent application. No. [Attorney Document No. ASP5110USNP.0635 277]. Other suitable ways in which subsystem 400 may be combined with reprocessing system 2 will be apparent to those skilled in the art in view of the teachings of the present invention.

Figure 4 shows a functional diagram of an exemplary fluid system 420 of subsystem 400. Fluid system 420 can be configured by batch processing or continuous processing of disinfecting solution 92. Fluid system 420 is connected to a first outlet 135 of reprocessing system 2. First outlet 135 provides circulation with first station 10. Fluid system 420 is also connected to a second outlet 235 of reprocessing system 2. Second outlet 235 provides circulation 12 with the second season. It should be understood that since second 12 is merely optional station, second output 235 is also merely optional.

The first outlet 135 is also in fluid communication with the first filter 402. The first filter 402 is in fluid communication with the first valve 404, which is normally in a closed position. If present, the second outlet 235 is also in fluid communication with a second filter 403. The second filter 403 is in fluid communication with the second valve 405, which is normally in a closed position. First normally closed valve 404 is opened when disinfection solution 92 is to be sampled from first station 10, and alternatively, second normally closed valve is opened when 405 disinfection solution 92 is to be sampled from second station 12 In either case, when the first and / or second valves 404, 405 are closed, and the engine (407 discussed below) is stopped, the subsystem 400 is in hold mode, and the disinfection solution 92 is free to flow to. and from reprocessing system 2. For continuous sampling of disinfecting solution 92 to occur, both first valve 404 and optional second valve 405 remain in an open state.

The fluid system 420 of the present example is also in fluid communication with reservoir 401 which is configured to contain reagent solution. Reservoir 401 is in fluid communication with first pump 406, while said first valve 404 and optional second valve 405 are fluid communication with second pump 408. In some versions, as shown in Figure 4, first pump 406 and the second pump 408 are simultaneously driven by the double-head stepper motor 407. The dual use of the double-head stepper motor 407 allows accurate and accurate control of the volumetric flow of reagent solution and disinfection solution 92 through the respective pumps 406, 408. For example, disinfecting solution 92 and reagent solution can be pumped simultaneously at a volumetric flow rate of about 1: 1. Alternatively, some other type of motor and / or pumping arrangement may be used to pump at a volumetric flow rate of about 1: 1, or any other desired volumetric flow rate. In addition, engine arrangements and / or pumping can be configured to change the volumetric flow rate in real time, such as by driving two different motors and two pumps to pump the disinfection solution respectively 92 and the reagent solution.

[0057] In the example shown in Figure 4, the first pump 406 is in fluid communication with the selector valve 409, which is in fluid communication with the first mixing chamber 410. The selector valve 409 controls the flow of reagent solution back. to reservoir 401 or first mixing chamber 410. In the present example, when selector valve 409 in the normally open state, reagent solution from reservoir flows 401, first pump 406 and back to reservoir 401, the which may allow the reagent feed line 501 to be purged and the reagent solution degassed. Various suitable devices and methods that can be used to purge and / or degass the reagent feed line 501 will be apparent to those skilled in the art in view of the teachings of the present invention. It should also be understood that such purging and degassing features are merely optional. Some versions may simply omit such purging and degassing features.

When disinfecting solution 92 is measured for disinfectant concentration, the normally open portion of selector valve 409 closes and the normally closed portion of selector valve 409 opens to allow reagent solution to flow from reservoir 401. through first pump 406, through first check valve 502 and into first mixing chamber 410. First check valve 502 prevents backflow of fluid from first mixing chamber 410 back through selector valve 409 and finally back to reservoir 401, where fluid may contaminate the reagent. For continuous sampling of disinfecting solution 92 to take place, selector valve 409 may remain in this position to continuously provide the reagent solution to the first mixing chamber 410.

In the fluid system 420 of the present example, the second pump 408 is also in fluid communication with the first mixing chamber 410. Thus, when the first valve 404 or, alternatively, a second valve 405 is in a open state, disinfection solution is pumped through the second check valve 503 and into the first mixing chamber 410. The second check valve 503 prevents backflow of fluid from the first mixing chamber 410 back to the second 408. As noted above, in the present example shown in Figure 4, the first pump 406 and the second pump 408 are simultaneously driven by the double-head stepper motor 407, which allows accurate and accurate control of volumetric solution flow. reagent solution and disinfection solution 92 respectively through pumps 406, 408. Thus volumes of reagent solution and disinfection solution 92 provided for the first mixing chamber 410 may be precisely controlled and therefore may be mixed at any desired ratio within the first mixing chamber 410 to create the sample solution. In some versions, the reagent solution and disinfection solution 92 may be mixed in a volume ratio of about 1: 1 to create a sample solution.

As shown in Figure 4, fluid system 420 is also connected to water inlet 137. Water inlet 137 is in fluid communication with third filter 414. Third filter 414 is in fluid communication with third valve. 413, which is normally in a closed position. Third normally closed valve 413 is opened when baseline concentration of reagent product is determined. When the third valve 413 is opened, one volume of water (rather than one volume of disinfecting solution 92) is mixed in the first mixing chamber 410 with one volume of reagent solution to create a control solution. In some versions, the reagent and water solution may be mixed in a volume ratio of about 1: 1 to create the control solution. The absorbance of the control solution is measured as described below and used by controller 450 to calculate the absorbance of the reaction product (s) of interest.

As shown in Figure 4, the first mixing chamber 410 may optionally be in fluid communication with the second mixing chamber 411. It is contemplated herein that more than two mixing chambers 410, 411 may be used. By way of example only, mixing chambers 410, 411 may each comprise a static mixer with a plurality of mixing elements. Various suitable forms which mixing chambers 410, 411 may take will be apparent to those skilled in the art based on the teachings of the present invention. One skilled in the art may choose the number of mixing chambers for inclusion in subsystem 400 based on a number of factors including, but not limited to, the sample mixing time required to generate the reaction product with concentration in the sample solution ( or control solution) which is measurable using subsystem 400 concentration analysis set 430. In either case, one or more of the mixing chambers 410, 411 are in fluid communication with the degassing module 500. Degassing 500 is operable to remove air bubbles from the liquid solution by passing through mixing chamber (or chambers) 410, 411. Degassing module 500 is in fluid communication with sample chamber 434. It should be understood that degassing module 500 is merely optional. In some versions, the degassing module 500 is completely omitted.

In the present example, the sample chamber 434 is a crucible having transparent (or otherwise optically transmissive) sides. Preferably, the crucible 434 is formed of optical quartz and has straight sides so that it has minimal interference in measuring light passing therethrough.

Depending on the desired chemical reaction when the reagent is mixed with the solution disinfecting solution 92, the temperature of the resulting sample solution may affect the absorbance measurement of the reaction product in the sample solution. Thus, in some versions, such as shown in Figure 4, subsystem 400 includes a temperature sensor 412, which is positioned so that it can measure the temperature of the sample solution as it passes from the mixing chamber. 410, 411 for sample chamber 434. Temperature sensor 412 measures the temperature of the sample solution to allow temperature corrections by a controller (not shown) when determining the disinfectant concentration in disinfection solution 92. It should be understood that the temperature sensor 412 is merely optional. In some versions, the 412 temperature sensor is omitted completely.

Subsystem 400 Concentration Analysis Set 430 is generally shown to comprise a 431 LED and a 443 photodiode sensor. The 431 LED is configured to emit light of first intensity 460 and wavelength to direct light through the sample chamber 434. Sensor 443 measures a portion of the light passing through the crucible 434 and having a second intensity 470.

Figure 5 shows another exemplary configuration that can be used to form the subsystem 400 concentration analysis set 430. The concentration analysis set 430 of Figure 5 comprises a light source 431 that emits light having the first known intensity 460 and wavelength. Light source 431 emits and directs light through the collimator 432, beam splitter 433, crucible 434 containing the sample solution and sensor 443. The crucible 434 can be formed of optical quartz and has straight sides for interference. measurement of light passing through it. A portion of light 490 is reflected to reference detector 423 so as to regulate a power supply 415 to light source 431 and to ensure consistent output thereof. The portion of the light passing through the crucible 434 has a second intensity 470. The portion of the light having a second intensity 470 then passes through the sensor 443 having the inlet filter, through which the light having a length of about 570 nm, about 120 nm can pass. Light output from the 480 443 sensor is sent to the 450 controller.

In some versions, the 431 light source emits light having a wavelength in the range of about 500 nanometers ("nm") to about 600 nm. More particularly, the light source 431 can emit light having a wavelength of about 570 nm. In some versions, the light source 431 may emit light of a first known intensity 460 of about 70 millicandela (mcd) to about 120 mcd. As subsystem 400 ages, the first known light intensity 460 can be adjusted by one of skill in the art to compensate for any aging effects on light intensity (e.g., increased subsystem 400 crucible window turbidity , etc).

The difference between the first known light intensity 460 and the second light intensity 470 is indicative of reaction product concentration in the sample solution or control solution. Controller 450 is configured to determine the concentration of reaction product in the sample solution based on light data detected from sensor 443 in accordance with the Beer-Lambert Law. Based on the concentration of the reaction product in the sample solution, controller 450 is configured to determine the disinfectant concentration in the disinfection solution 92.

As can be seen from Figure 5, a thermistor 412 is configured to measure the crucible temperature 434. The controller 450 can be configured to adjust the disinfectant concentration determination due to any thermal impact on the light measurements. , as detected by thermistor 412.

In some versions, the control system 20 is additionally configured to emit a warning signal when a disinfectant concentration in the disinfectant solution 92 is below a predetermined value that is indicative of disinfectant solution 92 which no longer contains a disinfectant. effective concentration of disinfectant. When the warning signal is sent, it indicates to a reprocessing system 2 user that the disinfection system 92 must be replaced to ensure that the disinfection solution 92 is sufficiently concentrated to provide effective sterilization or disinfection of the next endoscope (s). ) to be cleaned. By way of example only, the warning signal may comprise one or more of the following: an audible sound, a warning message 22 through visual display, a text message sent to the smartphone, a message sent to a computing device ( for example, a desktop computer, laptop, tablet, smartphone, etc.), and / or combinations thereof. The warning signal can also interface with a hospital inventory management system and automatically request release of more disinfectant solution 92 for reprocessing system 2. The warning signal can trigger the automatic request for more disinfectant solution 92 from a manufacturer. Other suitable forms that a warning signal may take, and other types of actions that may be triggered in response to a warning signal, will be apparent to those skilled in the art in view of the teachings of the present invention.

In the present example, for the OPA 92-containing disinfection solution to be effective over a given sterilization or disinfection cycle, the minimum effective OPA concentration in the disinfection solution 92 is about 0.3% by weight of the solution. For disinfection solution 92 to be effective in any given sterilization or disinfection cycle, and by way of example only, the minimum effective amount of PAA in disinfection solution 92 is about 0.10% to about 0.30% or about 0.15% to 0.25% by weight of disinfecting solution 92. More particularly, the minimum effective concentration of PAA 92 in the disinfecting solution may be about 0.15%. by weight of disinfection solution 92.

[0071] Determination of reaction product concentration in the sample solution can be performed in response to manual or automatic user input on a basis. For example, a user may push a button (for example, a "disinfectant concentration test," etc. button) to provide a manual input to initiate disinfectant concentration determination. Manual input can be provided on an ad hoc basis or on a periodic basis. If performed on an automatic basis, determination of disinfectant concentration can be initiated from selected bases: on a time basis (eg every Monday at 9:00) based on the number of uses (eg after every ten sterilization endoscopes), based on a Total cycle time (for example, after every ten hours sterilization cycles), and / or on some other basis, including combinations thereof.

As shown in Figure 4, if the solution is no longer in use, the sample is emitted from subsystem 400 concentration analysis set 430 through fluid outlet 174. Fluid outlet 174 may be coupled. to one or more drains, for example utility drain 74 of reprocessing system 2. IV. Exemplary Method for Measuring Disinfectant Concentration [0073] Subsystem 400 can measure disinfectant concentration in disinfectant solution 92 in reprocessing system 2. As shown in Figure 6, disinfectant concentration measurement begins with step 601, wherein the disinfecting solution stream 92 is directed into the first mixing chamber 410. Step 601 is performed simultaneously with step 602. In step 602, the reagent solution flow is directed into the first mixing chamber 410. Thereafter, in step 603, the disinfecting solution 92 and the reagent solution are mixed to create the sample solution. Step 604 is followed by step 603. In step 604, sample solution flow is directed into sample chamber 434 comprising transparent sides. Step 605 is followed by step 604. In step 605, light of the first known intensity and wavelength is passed through the sample chamber and the solution chamber in the sample chamber.

In some versions, step 605 is performed concurrently with step 606. In some other versions, steps 605, 606 are performed separately or overlapping in a sequence. At step 606, the second light intensity passed through the sample chamber and the sample solution in a sample chamber is measured. Step 607 is followed by step 606. In step 607, the concentration of reaction product in the sample solution is determined based on a difference between the first known light intensity and the second light intensity. Step 608 is followed by step 607. In step 608, the concentration of disinfectant in the disinfecting solution 92 is determined based on the concentration of the reaction product. Step 609 is followed by step 608. In step 609, the warning signal sent to disinfectant concentration in the disinfectant solution is below an effective concentration. See Examples of Reagent Solutions When disinfecting solution 92 is mixed with reagent solution, a sample solution is made. Examples of reagent solutions comprise one or more substances (s) which are reacted with disinfectant solution 92 to form reaction product (s) in the sample solution. As described in detail above, a concentration of reaction product (s) in the sample solution is measured and used to determine the concentration in the disinfectant solution 92.

Reagent solutions as described in the present invention may overcome problems associated with non-reagent based techniques for measuring the concentration of aldehyde-containing disinfectants by passing light through a sample thereof. For example, the present reagent solutions may react with disinfectant in a solution so that the absorbance of aldehydes and / or reaction products in the sample solution does not interfere with the measurement of disinfectant concentration. In addition, reagent solutions as described in the present invention may be used to correctly measure at a wider range of sample disinfectant solution concentrations (i.e. from very low to very high in sample concentration disinfectant solutions). In addition, the use of reagent solutions described herein may allow for greater precision in determining the disinfectant concentration in a sample solution, thereby allowing the exact determination of the disinfectant concentration around a point of interest, such as a minimum effective concentration of disinfectant. disinfectant present in the sample solution.

To measure the concentration of OPA 92 in the disinfection solution, a reagent solution comprising components with the following functions may be used: (a) reagents that will react with OPA to form hydroxide;

(B) acid to react with hydroxide;

(C) PH / species absorbance indicator;

(D) a solvent; and optionally (e) pH indicator / solubility enhancer of absorbance species.

Examples of reagents that will react with OPA to form hydroxide sulfites are selected from sodium sulfite, sodium bisulfite and combinations thereof.

Exemplary acids for reacting with hydroxide are selected from hydrochloric acid, sulfuric acid, nitric acid, phosphoric acid, organic carboxylic acids and combinations thereof. Examples of organic carboxylic acids are selected from acetic acid, formic acid, citric acid, oxalic acid, propionic acid, and combinations thereof.

PH indicators / species absorbance are selected from phenolphthalein, O-cresolphthalein, p-naphtholbenzene, ethyl bis (2,4-dimethylphenyl) acetate and thymolphthalein.

An exemplary solvent is water.

PH indicator / solubility enhancers of exemplifying absorbance species are selected from ethanol, n-propanol, n-butanol, isobutanol, propylene glycol, ethylene glycol, other dimethyl sulfoxides, N, N-dimethylformamide and combinations thereof. . Without sticking to the theory, solubility enhancers are believed to be.

An exemplary reagent solution for measuring the concentration of OPA in disinfecting solution 92 may be made by mixing, by weight, percent of the total weight of the reagent solution the following raw materials: [0088] (a) from about 1% to about 5%, or more particularly about 3%, of sodium sulfite;

(B) from about 0.1% to about 0.2% or more particularly about 0.175% 37% hydrochloric acid;

(C) from about 0.002% to about 0.008%, or more particularly about 0.004%, of phenolphthalein;

(D) from about 10% to about 20%, or more particularly 15.7%, of isopropanol; and (e) the balance being water, or more particularly 81.1% water.

After mixing the raw materials together, a reaction occurs between hydrochloric acid and sodium sulfite to produce sodium bisulfate and sodium chloride. Thus, the ready-to-use reagent solution for measuring the concentration of OPA in disinfecting solution 92 comprises: from about 1% to about 4.8%, or more particularly about 2, 78% sodium sulfite;

(B) from about 0.1% to about 0.3%, or more particularly about 0.185%, sodium bisulfate;

(C) from about 0.06% to about 0.12%, and more particularly about 0.104%, of sodium chloride;

(D) from about 0.002% to about 0.008%, or more particularly about 0.004%, of phenolphthalein;

(E) from about 10% to about 20%, or more particularly 15.7%, of isopropanol; and (f) wherein the balance consists of water or, more particularly, 81.2% water.

Without sticking to the theory, it is believed that when ready for use, the reagent solution for measuring the concentration of OPA is mixed with the disinfection solution 92, OPA present in the disinfection solution 92 reacts with the sulfur sulfide. excess sodium to quantitatively generate hydroxide, which is neutralized by a controlled amount of acid including reagent solution acid and dihydrogen phosphate and benzotriazole OPA solution. If OPA is present in disinfection solution 92 at a concentration greater than about 0.3% by weight of disinfection solution 92, then excess hydroxide will be generated in the sample solution, resulting in an increase in phenolphthalein pH and absorbance. which are interpreted by controller 450 as "pass". If, on the other hand, OPA present in disinfection solution 92 below about 0.3% by weight of disinfection solution 92, then excess acid may be present in the sample solution, resulting in a decrease in pH and phenolphthalein absorbance which are interpreted by controller 92 for reading as "failure".

To measure the concentration of PAA in the disinfecting solution 92, an exemplary reagent solution comprising soluble io-deto (or iodides) may be used. Examples of soluble iodide are selected from potassium iodide, sodium iodide, calcium iodide, magnesium iodide and combinations thereof. By mixing the reagent solution with disinfectant solution containing PAA 92 to form a sample solution, PPA reacts with the soluble iodide at about a 1: 1 volume ratio to form iodine in the sample solution. Controller 450 is configured to use absorbance iodine in the sample to determine the PAA concentration in disinfecting solution 92. VI. Exemplary Combinations The following examples refer to various non-exhaustive forms in which the teachings of the present invention may be combined or applied. It should be understood that the following examples are not intended to restrict the coverage of any claims that may be made at any time in this application or on deposits subsequent to this application. No waiver of rights is intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings of the present invention may be arranged and applied in various other ways. It is also contemplated that some variations may omit certain features referred to in the examples below. Therefore, none of the features or features listed below should be considered critical unless explicitly stated otherwise at a later date made by the inventors or a successor of interest to the inventors. If any claims are made in this application or subsequent filings related to this application that include additional features in addition to those noted below, these additional features are not presumed to have been added for any reason relating to patentability. Example 1 A medical instrument processor comprising: (a) a housing for holding an instrument; (b) a liquid dispensing system configured to apply a disinfecting solution to a medical instrument within the enclosure, the liquid dispensing system comprising a liquid outlet; (c) a disinfectant concentration measurement subsystem comprising: (i) a first mixing chamber in fluid communication with the liquid outlet, (ii) a reservoir configured to contain a reagent solution, wherein the reservoir is in communication fluid with the first mixing chamber, (iii) a pump that is configured to simultaneously pump disinfection solution and reagent solution into the first mixing chamber, and (iv) a concentration set, which is operable for analysis to Determine the concentration of disinfectant in a sample solution, which is emitted from the first mixing chamber.

Example 2 The medical instrument processor of claim 1, wherein the concentration analysis assembly comprises: (A) a sample chamber comprising optically transmissive sides, (B) a light source configured to pass light from a first intensity and wavelength known through the sample chamber and the sample solution in the sample chamber, and (C) a sensor configured to measure a second intensity of light passing through the sample chamber and the sample solution in the sample chamber. sample.

Example 3 The medical instrument processor of claim 2, wherein the light source comprises a light emitting diode.

Example 4 The medical instrument processor of claim 2, wherein the sensor comprises a photodiode.

Example 5 The medical instrument processor of claim 2, wherein the disinfectant concentration measurement subsystem further comprises a control system which is configured to: (i) determine a concentration of reaction product in the sample solution with based on a difference between the first and second intensity and the light intensity, and (ii) determine a disinfectant concentration in the disinfection solution based on the concentration of the reaction product in the sample solution.

Example 6 The medical instrument processor of claim 5, wherein the control system is further configured to emit a warning signal when the disinfectant concentration in the disinfectant solution is below a predetermined value.

Example 7 The medical instrument processor of claim 5, wherein the disinfectant comprises orthophthalaldehyde and the reaction product comprises sodium hydroxide.

Example 8 The medical instrument processor of claim 5 wherein the disinfectant comprises peracetic acid and the reaction product comprises iodine.

Example 9 The medical instrument processor of claim 5, wherein the disinfectant concentration measurement subsystem further comprises a temperature sensor configured to measure the temperature of the sample solution.

Example 10 The medical instrument processor of claim 9, wherein the control system is further configured to adjust the disinfectant concentration in the disinfectant solution based on a temperature of the sample solution.

Example 11 The medical instrument processor of claim 1, wherein the pump comprises a dual head stepper motor. Example 12 The medical instrument processor of claim 1, wherein the pump is configured to simultaneously pump disinfection solution and reagent solution at a volumetric flow rate of about 1: 1.

Example 13 The medical instrument processor of claim 1, wherein the disinfectant is selected from orthophthalaldehyde and peracetic acid.

Example 14 The medical instrument processor of claim 1, wherein the mixing chamber comprises a static mixer. Example 15 The medical instrument processor of claim 1, wherein the disinfectant concentration measurement subsystem further comprises a second mixing chamber in fluid communication with the first mixing chamber.

Example 16 A method for measuring a concentration of a disinfectant in a disinfectant solution of a medical instrument processor, the method comprising: (a) directing a flow of the disinfectant solution into a first mixing chamber; (b) directing a flow of a reagent solution into the first mixing chamber; (c) mixing the disinfecting solution and reagent solution in the first mixing chamber to create a sample solution; (d) directing the sample solution into a sample chamber comprising transparent sides; (e) passing the first light having a known first intensity and wavelength through transparent sides of the sample chamber and the sample solution in the sample chamber; (f) measuring a second intensity of light transmitted through the sample chamber and the sample solution in the sample chamber; (g) determining a concentration of reaction product in the sample solution based on a difference between the first known intensity and the second light intensity; and (h) determining the disinfectant concentration in the disinfection solution based on the concentration of the reaction product.

Example 17 The method of claim 16, wherein the disinfectant is selected from orthophthalaldehyde and peracetic acid.

Example 18 The method of claim 16, wherein the disinfecting solution and the reagent solution are mixed at a volume to volume ratio of about 1: 1 to create the sample solution. Example 19 The method of claim 13, further comprising issuing a warning signal when the disinfectant concentration in the disinfecting solution is below a predetermined value. Example 20 A reagent solution for measuring the concentration of OPA in disinfecting solution 92 is made by mixing, by weight, percent of the total weight of the reagent solution, the following raw materials: (a) about 1% to about 5% sodium sulfite; (b) from about 0.1% to about 0.2% 37% hydrochloric acid; (c) from about 0.002% to about 0.008% phenolphthalein, and (d) from about 10% to about 20% isopropanol; and (e) a water balance.

Example 21 A reagent solution for measuring the concentration of OPA in disinfecting solution 92 is made by mixing, by weight, percent of the total weight of the reagent solution the following raw materials: (a) about 3 % sodium sulfite; (b) about 0.175%, 37% hydrochloric acid; (c) about 0.004% phenolphthalein; (d) about 15.7% isopropanol; and (d) about 81.1% water. Example 22 A ready-to-use reagent solution comprises as a percentage by weight of the total weight of the ready-to-use reagent solution: (a) from about 1% to about 4.8% sodium sulfite; (b) from about 0.1% to about 0.3% sodium bisulfate; (c) from about 0.06% to about 0.12% sodium chloride; and (d) from about 0.002% to about 0.008% phenolphthalein; (e) about 10% to about 20% isopropanol; and (f) a water balance.

Example 23 A ready-to-use reagent consisting essentially of: a) from about 1% to about 4.8% sodium sulfite; (b) from about 0.1% to about 0.3% sodium bisulfate; (c) from about 0.06% to about 0.12% sodium chloride; and (d) from about 0.002% to about 0.008% phenolphthalein; (e) from about 10% to about 20% isopropanol; and (f) a water balance.

Example 24 A ready-to-use reagent consisting essentially of: a) about 2.78% sodium sulfite; (b) about 0.185% sodium bisulfate; (c) about 0.104% sodium chloride; (d) about 0.004% phenolphthalein; (e) about 15.7% isopropanol; and (f) about 81.2% water. VII. Miscellaneous It should be understood that any patent, publication, or other disclosure material incorporated by reference into this invention by reference in whole or in part is incorporated into the present invention only insofar as the incorporated material does not come into conflict with the definitions, statements or other disclosed material set forth in this disclosure. Accordingly, and to the extent necessary, disclosure as explicitly set forth herein supersedes any conflicting material incorporated by reference into the present invention. Any material, or portion thereof, incorporated herein by reference but which conflicts with the definitions, statements, or other disclosure materials contained herein is incorporated herein only to the extent that there is no conflict between the material incorporated and existing disclosure material.

Having shown and described various embodiments of the present invention, other adaptations of the methods and systems described in the present invention may be made by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of these possible modifications have been mentioned, and others will become apparent to those skilled in the art. For example, the examples, embodiments, geometry, materials, dimensions, proportions, steps, and the like discussed above are illustrative and not required. Accordingly, the scope of the present invention should be considered in accordance with the terms of the following claims and it is understood that it is not limited to the details of structure and operation shown and described in the specification and drawings.

Claims (20)

1. Medical instrument processor, characterized in that it comprises: (a) a housing intended to contain a medical instrument; (b) a liquid dispensing system configured to provide a disinfecting solution for a medical instrument within the enclosure, the liquid dispensing system comprising a liquid outlet; (c) a disinfectant concentration measurement subsystem comprising: (i) a first mixing chamber in fluid communication with the liquid outlet (ii) a reservoir configured to contain a reagent solution, wherein the reservoir is in fluid communication with the first mixing chamber, (iii) a pump that is configured to simultaneously pump disinfection solution and reagent solution into the first mixing chamber, and (iv) a concentration analysis assembly that is operable to determine a concentration of disinfectant in a sample solution that is supplied from the first mixing chamber. Medical instrument processor according to claim 1, characterized in that the concentration analysis assembly comprises: (A) a sample chamber comprising optically transmissive sides, (B) a configured light source for passing light of a known first intensity and wavelength through the sample chamber and the sample solution in the sample chamber, and (C) a sensor configured to measure a second intensity of light passing through the sample chamber and the sample solution in the sample chamber. Medical instrument processor according to claim 2, characterized in that the light source comprises an LED. The medical instrument processor of claim 2, the sensor characterized in that it comprises a photodiode. Medical instrument processor according to claim 2, characterized in that the concentration measurement subsystem further comprises a control system which is configured to: (i) determine a concentration of the reaction product in the sample solution based on a difference between the first intensity and the second light intensity, and (ii) determine a disinfectant concentration in the disinfection solution based on the reaction product concentration in the sample solution. Medical instrument processor according to claim 5, characterized in that the control system is further configured to emit a warning signal when the disinfectant concentration in the disinfectant solution is below a predetermined value. Medical instrument processor according to claim 5, characterized in that the disinfectant comprises orthophthalaldehyde and the reaction product comprises sodium hydroxide. Medical instrument processor according to claim 5, characterized in that the disinfectant comprises peracetic acid and the reaction product comprises iodine. Medical instrument processor according to claim 5, characterized in that the disinfectant concentration measurement subsystem further comprises a temperature sensor configured to measure a temperature of the sample solution. Medical instrument processor according to claim 9, characterized in that the control system is further configured to adjust the disinfectant concentration in the disinfection solution based on the temperature of the sample solution. Medical instrument processor according to claim 1, characterized in that the pump comprises a dual-head stepper motor. Medical instrument processor according to claim 1, characterized in that the pump is configured to simultaneously pump the disinfection solution and the reagent solution at a volumetric flow rate of about 1: 1. Medical instrument processor according to claim 1, characterized in that the disinfectant is selected from orthophthalaldehyde and peracetic acid. Medical instrument processor according to claim 1, characterized in that the disinfectant concentration measurement subsystem further comprises a second mixing chamber in fluid communication with the first mixing chamber. Medical instrument processor according to claim 1, characterized in that the mixing chamber comprises a static mixer. A method of measuring a concentration of a disinfectant in a disinfectant solution of a medical instrument processor, the method comprising: (a) directing a disinfectant solution flow into a first mixing chamber; (b) directing a flow of a reagent solution into the first mixing chamber; (c) mixing the disinfecting solution and reagent solution in the first mixing chamber to create a sample solution; (d) directing the sample solution into a sample chamber comprising transparent sides; (e) passing light having a known first intensity and wavelength through the transparent sides of the sample chamber and the sample solution in the sample chamber; (f) measuring a second intensity of light transmitted through the sample chamber and the sample solution in the sample chamber; (g) determining a reaction product concentration in the sample solution based on a difference between the first known intensity and the second light intensity; and (h) determining the disinfectant concentration in the disinfection solution based on the concentration of the reaction product. Method according to claim 16, characterized in that the disinfectant is selected from orthophthalaldehyde and peracetic acid. Method according to claim 16, characterized in that the disinfecting solution and the reagent solution are mixed in a volume ratio of about 1: 1 to create the sample solution. Method according to claim 13, characterized in that it further comprises issuing a warning signal when the concentration of disinfectant in the disinfectant solution is below a predetermined value. 20. A ready-to-use reagent solution, comprising as a percentage by weight of the total weight of the reagent solution: (a) from about 1% to about 5% sodium sulfite; (b) from about 0.002% to about 0.008% phenolphthalein; (c) from about 0.1% to about 0.2%, (d) from about 10% to about 20% isopropanol; and (e) a water balance; wherein the reagent solution is configured to measure the orthophthalaldehyde concentration in a liquid sample.